Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05994638

Enrollment

Registered

2023-08-16

Start date

2023-08-21

Completion date

2023-11-30

Last updated

2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Mucositis

Keywords

Radiotherapy, Head and neck cancer, Dysphagia, Oral Mucositis

Brief summary

The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.

Detailed description

The study will be conducted on a group of 10 patients with head and neck cancer who have undergone radiation therapy and experience side effects such as discomfort/changes in the oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before and after the study, an assessment questionnaire related to the side effects of radiation therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.

Interventions

DIETARY_SUPPLEMENTAerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)

Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Women and men, 18-75 years old * Patients with head and neck cancer or other types of cancer after radiotherapy who suffer from oral mucositis * Patients with dryness in mouth * Signed informed consent.

Exclusion criteria

* Intake of supplements containing plant extracts, polyphenols or anthocyanins * Participation in another clinical trial, * Women who are pregnant, planning to become pregnant during the study or breastfeeding, * Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation. * Hypersensitivity/allergy to any of the ingredient

Design outcomes

Primary

Measure	Time frame	Description
Side effects after radiotherapy	Baseline, 1 month	Based on a questionnaire

Secondary

Measure	Time frame	Description
Impact of dysphagia on quality of life	Baseline, 1 month	Based on a MDADI questionnaire

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026